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临床试验/NCT07335172
NCT07335172尚未招募不适用

Bedside Gastric Ultrasound Before Elective Cesarean Section: Observational Study

Ekin Deniz KUTLU0 个研究点目标入组 80 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
Obstetric Ultrasonographic Assessment: Gastric volume

研究概览

简要总结

Due to the physiologically delayed gastric emptying in pregnant women, the potential risk of aspiration before cesarean delivery constitutes an important source of perioperative complications, and when it occurs, it is associated with increased maternal morbidity and/or mortality. Systematic reviews and meta-analyses have demonstrated that, compared with non-pregnant women, gastric emptying is delayed particularly during the first trimester of pregnancy, and that gastric emptying does not occur in cases who have consumed solid food within the last 8 hours and in whom labor has begun.

This study aims to evaluate preoperative gastric volumes by ultrasonography in ASA II pregnant women (according to the American Society of Anesthesiologists classification, healthy parturients without complications) scheduled to undergo elective cesarean delivery under general or spinal anesthesia, based on different fasting durations for solid and liquid intake, with the type of liquid.

Although previous research in pregnant populations has predominantly focused on the importance of gastric ultrasonography in the presence of gestational diabetes mellitus, this thesis study aims to generate data from the general population. The findings are expected to enable individualized preventive measures to reduce aspiration-related complications during cesarean deliveries performed under general or spinal anesthesia, thereby contributing to patient safety.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 18-45 years
  • Term pregnant women classified as ASA II scheduled for elective cesarean section
  • Those who voluntarily agree to participate in the study

排除标准

  • Cases requiring emergency (Lucas classification based on the urgency of caesarean section, Category 1-2)
  • Multiple pregnancies

研究组 & 干预措施

ASA II term pregnant women aged 18-45 years scheduled for elective cesarean delivery

结局指标

主要结局

Obstetric Ultrasonographic Assessment: Gastric volume

时间窗: 60-90 minutes before surgery

1\. Obstetric Ultrasonographic Assessment: Gastric Volume Gastric volume will be calculated by ultrasonography (with two mathematical models from the literature) before elective cesarean delivery and recorded in milliliters.

Time of last solid food / liquid intake The time of the last solid food and liquid intake by the pregnant women will be recorded in hours. Liquid type will be also recorded.

时间窗: 60-90 minutes before surgery

The time of the last solid food and liquid intake by the pregnant women will be recorded in hours. Liquid type will be also recorded.

次要结局

  • Preoperative data(60-90 minutes before surgery)

研究者

发起方
Ekin Deniz KUTLU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ekin Deniz KUTLU

Anesthesiology and Reanimation researcher/ Doctor

Gazi University

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Gastric Ultrasound Before Elective Cesarean Section | 临床试验